The following data is part of a premarket notification filed by Nalu Medical, Inc with the FDA for Nalu Neurostimulation Kit (integrated, 40 Cm: Single 8/dual 8), Nalu Neurostimulation Kit (ported, 2 Cm: Single 8/dual 8), Dual 8 Ported Nalu Implantable Pulse Generator With 40 Cm Kit, 40 Cm/ 60 Cm Trial/extension Lead Kits, Patient Kits And Miscell.
| Device ID | K183579 |
| 510k Number | K183579 |
| Device Name: | Nalu Neurostimulation Kit (Integrated, 40 Cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 Cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator With 40 Cm Kit, 40 Cm/ 60 Cm Trial/Extension Lead Kits, Patient Kits And Miscell |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | Nalu Medical, Inc 1525 Faraday Ave. Suite 180 Carlsbad, CA 92008 |
| Contact | Michele Chin-purcell |
| Correspondent | Michele Chin-purcell Nalu Medical, Inc 1525 Faraday Ave. Suite 180 Carlsbad, CA 92008 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-03-29 |